FDA.reportPublic FDA data

Cough HP

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:19:35

Label at a glance#

ProductCough HP
Active ingredientARSENIC TRIOXIDE, BRYONIA ALBA ROOT, CUPRIC ACETATE, DROSERA ROTUNDIFOLIA, IPECAC, POTASSIUM CARBONATE, PHOSPHORUS, PULSATILLA VULGARIS, SPONGIA OFFICINALIS SKELETON, ROASTED
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Arsenicum Album 30X, Bryonia Alba 30X, Cuprum Aceticum 30X, Drosera Rotundifolia 30X, Ipecacuanha 30X, Kali Carbonicum 30X, Phosphorus 30X, Pulsatilla 30X, Spongia Tosta 30X.

INDICATIONS & USAGE SECTION

USES: Temporarily relieves dry, violent cough, with hoarseness and/or painful larynx.**

OTC - PURPOSE SECTION

USES: Temporarily relieves dry, violent cough, with hoarseness and/or painful larynx.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults and children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • A persistant cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur or is accompanied by fever, rash, or persistent headache, consult a doctor.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

* The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406-0014-1

Cough HP

HOMEOPATHIC

 1 fl oz (30mL) / 20% Alcohol

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0014-12023-01-13C16284748780-19855d018-e612-cd31-e053-dbdaa90ab51aCough HP
43406-0014-12019-11-27C16284748780-19855d018-e612-cd31-e053-dbdaa90ab51aCough HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0014-1Cough HP30 mL in 1 BOTTLE, DROPPERLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0014COUGH HP (ARSENICUM ALBUM, BRYONIA ALBA, CUPRUM ACENTICUM, DROSERA ROTUNDIFOLIA, IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, PULSATILLA, SPONGIA TOSTA) LIQUID [NATURAL CREATIONS, INC]2Current NDC, Legacy NDC, 1 package rows20230113_62ae8d8f-67c8-4347-b910-a173d8283b18.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
CUPRIC ACETATEACTIVE INGREDIENT39M11XPH031
DROSERA ROTUNDIFOLIAACTIVE INGREDIENTQR44N9XPJQ1
IPECACACTIVE INGREDIENT62I3C8233L1
PHOSPHORUSACTIVE INGREDIENT27YLU75U4W1
POTASSIUM CARBONATEACTIVE INGREDIENTBQN1B9B9HA1
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE INGREDIENT1PIP394IID1
ARSENIC CATION (3+)ACTIVE MOIETYC96613F5AV1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CARBONATE IONACTIVE MOIETY7UJQ5OPE7D1
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
DROSERA ROTUNDIFOLIAACTIVE MOIETYQR44N9XPJQ1
IPECACACTIVE MOIETY62I3C8233L1
PHOSPHORUSACTIVE MOIETY27YLU75U4W1
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV1
SPONGIA OFFICINALIS SKELETON, ROASTEDACTIVE MOIETY1PIP394IID1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-001443406-0014-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CUPRIC ACETATE39M11XPH03ACTIB
DROSERA ROTUNDIFOLIAQR44N9XPJQACTIB
IPECAC62I3C8233LACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
PHOSPHORUS27YLU75U4WACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough HPARSENICUM ALBUM, BRYONIA ALBA, CUPRUM ACENTICUM, DROSERA ROTUNDIFOLIA, IPECACUANHA, KALI CARBONICUM, PHOSPHORUS, PULSATILLA, SPONGIA TOSTANatural Creations, Inc62ae8d8f-67c8-4347-b910-a173d8283b182022-11-23WarningsExact identifier
ndc (package): 43406-0014-1
ndc (product): 43406-0014
ndc11 (package): 43406001401
spl id: bcc9b7d6-9ae7-40ea-874c-83f68f707c84
spl set id: 62ae8d8f-67c8-4347-b910-a173d8283b18

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.